The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval for Takeda’s Hyqvia [immune globulin infusion 10% (human) with recombinant human hyaluronidase] for chronic inflammatory demyelinating polyneuropathy (CIDP).
Hyqvia is intended for usage as a maintenance treatment following stabilisation with intravenous immunoglobulin therapy (IVIG).
Go deeper with GlobalData
The CHMP suggestion will be taken into account by the European Commission (EC) in its decision on Hyqvia to treat CIDP.
The prospective indication expansion is based on positive findings from the placebo-controlled, multicentre, double-blinded Phase III ADVANCE-CIDP 1 clinical trial of Hyqvia as maintenance therapy in adult CIDP patients.
The trial analysed the safety, efficacy and tolerability of Hyqvia in 132 adult patients.
Hyqvia treatment offered a statistically significant decline in relapse rate, meeting its primary endpoint.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataTakeda plasma-derived therapies business unit research and development head and senior vice-president Kristina Allikmets stated: “Takeda is focused on bringing its differentiated immunoglobulin therapies to patients with neuroimmunological disorders, providing treatment options that address the needs of a broad range of patients.
“This positive CHMP opinion is a crucial step towards bringing patients with CIDP and their caregivers an effective therapy that, if approved, may offer maintenance treatment personalisation through up to once-monthly facilitated subcutaneous administration at home or in office.”
The US regulator is reviewing Hyqvia for the same indication.
The treatment is already approved in the US and Europe as a replacement therapy in adults, children and adolescents with primary and secondary immunodeficiency.
The latest development comes after the EC approved a label expansion of the company’s Takhzyro (lanadelumab) for patients aged two years and older for the routine prevention of recurrent attacks of hereditary angioedema (HAE).
The label expansion is based on the prior approval for Takhzyro for routine prevention of recurrent HAE attacks in patients aged 12 years and older.
